“TYPES” and “CLASSES” of Medical Devices

          To understand in detail please Read the below mentioned description.

 TYPES Of Medical Devices:
1)     Diagnostic Devices
                 E.g. : Diagnostic imaging equipment (X-Ray Machine, MRI Machine), In Vito Diagnostic
Devices {IVDD} (Blood Test, Pregnancy Test) and Diagnostic reagent
 
2)     Therapeutic Devices
                 E.g. : Surgical Instruments (Scalpels, Forceps), Implantable Devices (Pacemaker,
Artificial joints) and Drug Delivery Devices (Insulin Pens, Inhalers)
 
3)     Monitoring Devices
                E.g. :    Patient Monitoring devices (Heart Rate Monitor, Blood Pressure Monitors),
Wearable Devices (Fitness trackers) and home health monitoring devices
 
4)     Supportive Devices
                 E.g. :  Walking Aids (Crutches, Walkers), Prosthetics and Orthotics
 
5)     Consumables
                 E.g. : Surgical Gloves, Bandages and Catheters

CLASSES in Medical Devices:

1)     CLASS I: 
        These are the device that are considered as lowest level of risk among the medical devices.
E.g. Stethoscopes, Bandages, tongue depressors
 
2)     CLASS II:
        These devices are moderate-risk devices with special control such as Labelling, Post Market
Surveillance E.g. Infusion Pumps, Surgical Instruments, and Screening Devices
 
3)     CLASS III:
        These are high risk devices that are more stringent to regulatory control and require
approval from the regulatory authorities before it is marketed E.g. Pacemaker, Artificial heart
valves and other surgical implants
Note:       
     It is very important to classify your medical device with respect to the regulatory
requirements. Classification may vary based on the type of testing the device performs.